Class Im MD A novel device for Automated Analysis of Tear Film Dynamics. Michael Ring, DI(FH) Upper Austria University of Applied Sciences

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1 Class Im MD A novel device for Automated Analysis of Tear Film Dynamics Michael Ring, DI(FH) Upper Austria University of Applied Sciences

2 Aim of the Research Develop a method to give information on the Tear Film Seite 2

3 Structure of Tear Film Lubricating Tears balance of mucous, water, oil, nutrient proteins, antibodies Oil (100nm): optical smoothness, avoids hyperevaporation Aqueous layer (6 10 micros): oxygen, nutrients for cornea Mucus (30 40nm): Border between A. layer Epithelial cells Reflex Tears flooding due to irritation Seite 3

4 Pathophysiology Keratoconjunctivits sicca, Dry Eye Disease Symptoms scarring, corneal burns, decrease of optical performance, chronical damage of cornea Seite 4

5 Common Methods Schirmer test TBUT Rose Bengal Questionnaire Seite 5

6 New Approach Seite 6

7 Automated Analysis I Automated Analysis of Tear Break Up Seite 7

8 Automated Analysis II Automated Analysis of Lipid Layer Movement Seite 8

9 Seite 9

10 Intended Use The device is intended to provide videos of the tear film dynamics, which are further interpreted automatically by the software. These parameters give information on the stability of the tear film. It is designed to be used in dry rooms, the investigation is performed non invasively (without directly touching the eye) and only by professional trained persons. One investigation lasts about four minutes, the patient s skin around the eye thereby gets in surface contact with non metallic parts of the device. During the analysis the patient s eye is illuminated with light in the visible wavelength spectrum. (Questions EN ISO 14971:2007, Appendix C) Seite 10

11 Harmonized s Directive 93/42 EWG Essential Requirements, MPG Intended Use Classification Development QM RM Production Placing on the Market Post Market Surveillance Usabilit y Seite 11

12 Harmonized s Directive 93/42 EWG Essential Requirements, MPG Intended Use Classification DIN EN ISO DIN EN ISO ÖVE/ÖNORM EN DIN EN EN ISO :2007 ISO 14155: 2003 IEC 62366:2007 ÖVE/ÖNORM EN 62304, ÖVE/ÖNORM EN 62304, Seite 12

13 93/42 EWG MPG Definitions What is a medical device? Who is the manufacturer? Classification due to duration, invasivity, used within central nervous system 93/42 EWG / Annex IX, Rule Nr. 10 Active devices intended for diagnosis are in Class IIa: if they are intended to supply energy which will be absorbed by the human body, except for devices used to illuminate the patient's body, in the visible spectrum 93/42 EWG / Annex IX, Rule Nr. 12 Class Im MD All other active devices are in Class I CE conformity assessment procedure Essential Requirements specific laws (risk management, quality management system ) Seite 13

14 Risk Management Process DIN EN ISO Seite 14

15 DIN EN ISO Risk Management Process Risk Analysis identification of Potential Risks EN device software Software life cycle processes IEC 62366:2007 Application of usability engineering to medical devices estimation of Risk: likelihood x severity of damage Evaluation of Risks Risk Control evaluate possible Safety Arrangements new risks? Evaluation of Remaining Risks remaining risk acceptable? Final Report & Update incoming Information after Placing on the Market Seite 15

16 Example of Risk Management Step I Identification of Risk Hazard because of viruses and/or bacterias Predictable sequence of events Patient brings pathogens on the eye cup. Because of insufficient cleaning after the investigation, the next patient gets infected due to the contamination. Hazardous situation Patient s skin gets in direct contact with pathogens Harm Inflammation around the eye Seite 16

17 Example of Risk Management Step II Hazard because of viruses and/or bacterias Evaluation of risk Insignificant Severe Critical Catastrophic Common R2 Medium R7 R3, R4, R5 Rare R8 R6 R1 Risk control Provide eyecup foil for one time usage Re evaluation of risk Insignificant Severe Critical Catastrophic Common Medium R7 Rare R6,R1 R3, R4, R5 R2 Seite 17

18 Example I EN ISO :2007 Ophthalmic instruments Fundamental requirements and test methods Seite 18

19 EN ISO :2007 Ophthalmic instruments Fundamental requirements and test methods Optical radiation safety for ophthalmological devices Spectrum of illumination Sensitivity of the eye Radiation intensity on retina Seite 19

20 EN ISO :2007 Ophthalmic instruments Fundamental requirements and test methods Seite 20

21 Example II ÖVE/ÖNORM EN device software Software life cycle processes Seite 21

22 ÖVE/ÖNORM EN SW risk classification Class A No possible damage or harm to patient possible Class B No serious harm is possible Class C Death or serious harm is possible (implantable cardiac pacemaker) Nötige Prozesse, Aktivitäten, Aufgaben Seite 22

23 ÖVE/ÖNORM EN Processes [Depending on Risk Classification] SW Development P. - planning, analysis, design, implementation SW Maintenance P. - plan for maintenance / changes of SW Risk Management P. - Analysis for risks caused / controlled by SW SW Configuration Management P. - identify SW components, administrative and technical rules for changes of components & integrate them in project Problem Solution P. - more detailed process to identify trends, analyze problems Seite 23

24 ISO 14155: 2003 Clinical investigation of medical devices for human subjects Seite 24

25 ISO 14155: 2003 Clinical investigation of medical devices for human subjects I. Development of the prototype according to technical directives II. Ethics Commission III. Department of Health IV. Start of V. Evaluation of Seite 25

26 ISO 14155: 2003 Clinical investigation of medical devices for human subjects Who is the clinical tester, the monitor, the sponsor of the study Patient information sheet / Clinical Tester s handbook Indications / Contraindications Data Management Study Design control group? number of patients? blindness? randomization? prospective vs. retrospective? data management data analysis Incidents? Termination of study? Final report Seite 26

27 Thank you! Seite 27

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